Low-dose aspirin for preventing intrauterine growth restriction and pre-eclampsia in sickle cell pregnancy (PIPSICKLE): a randomised controlled trial (study protocol)

Afolabi, Bosede Bukola; Babah, Ochuwa Adiketu; Adeyemo, Titilope A.; Odukoya, Oluwakemi Ololade; Ezeaka, Chinyere; Nwaiwu, Obinyo; Oshodi, Yusuf A; Ogunnaike, Babatunde A.

doi:10.1136/bmjopen-2020-047949

Cited by 8 publications

(6 citation statements)

References 19 publications

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“…By 2022, the American College of Obstetricians and Gynecologists recommended low-dose aspirin use in women with SCD starting at 12-weeks gestation, 20 and a clinical trial of low-dose aspirin to prevent preeclampsia in SCD is ongoing. 21 There is not yet disease-specific evidence to guide peripartum or postpartum anticoagulation use in pregnant people with SCD without a history of thrombosis. A clinical trial is assessing the feasibility of chronic transfusion in SCD pregnancy ( NCT03975894 ).…”

Section: Discussionmentioning

confidence: 99%

“…By 2022, the American College of Obstetricians and Gynecologists recommended low-dose aspirin use in women with SCD starting at 12-weeks gestation, 20 and a clinical trial of low-dose aspirin to prevent preeclampsia in SCD is ongoing. 21 There is not yet disease-specific All adjusted odds ratios (aORs) were significant after using the Benjamini-Yekutieli correction. aORs adjusted for patient age, public insurance status, and income quartile by zip code, as well as hospital geographical region, bed size, teaching status, and ownership.…”

Section: Discussionmentioning

confidence: 99%

“…At present, when and how to use SCD treatments during pregnancy is not established. By 2022, the American College of Obstetricians and Gynecologists recommended low-dose aspirin use in women with SCD starting at 12-weeks gestation, and a clinical trial of low-dose aspirin to prevent preeclampsia in SCD is ongoing . There is not yet disease-specific evidence to guide peripartum or postpartum anticoagulation use in pregnant people with SCD without a history of thrombosis.…”

Section: Discussionmentioning

confidence: 99%

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Severe Maternal Morbidity and Mortality in Sickle Cell Disease in the National Inpatient Sample, 2012-2018

et al. 2023

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ImportancePregnancy outcomes are historically poor among people with sickle cell disease (SCD) in the US, most of whom have Black race. Whether outcomes have improved is unknown.ObjectiveTo tabulate adverse pregnancy outcomes among patients with SCD, comparing outcomes of deliveries among Black people with SCD with those of Black people without SCD and a control non-Black population, and to measure the association of racial disparities with adverse outcomes in SCD pregnancies.Design, Setting, and ParticipantsThis cross-sectional study was a secondary analysis involving data from National Inpatient Sample, a nationally representative sample of 20% of acute hospital admissions in the US, between 2012 and 2018. The data set included all admissions with codes for delivery of a pregnancy among people aged 11 to 55 years. Data were analyzed from September 2021 to August 2022.ExposuresSCD, racial disparities.Main Outcomes and MeasuresSevere maternal morbidity (SMM) as measured by the US Centers for Disease Control and Prevention’s index alongside other outcomes; multiple logistic regression was used to compare the odds for adverse pregnancy outcomes.ResultsThe sample included 5 401 899 deliveries, including 3901 deliveries among people with SCD and 742 164 deliveries among people with Black race. Compared with the non-Black control group, patients with SCD and Black patients were younger (mean [SD] age: SCD, 27.2 [5.9] years; Black, 27.1 [6.1] years vs 28.7 [5.9] years) and more likely to have public insurance (SCD, 2609 deliveries [67.3%]; Black, 496 828 deliveries [65.4%] vs 1 880 198 deliveries [40.8%]). The maternal mortality rate in deliveries among people with SCD was 26 times greater than in the non-Black control group and more than 10 times greater than among Black pregnant people without SCD (Per 10 000 deliveries: SCD 13.3; 95% CI, 5.7-31.2; Black race, 1.2; 95% CI, 1.0-1.5; non-Black control 0.5; 95% CI, 0.5-0.6). Compared with the control group, SCD deliveries had higher odds of SMM (adjusted odds ratio [aOR], 7.22; 95% CI, 6.25-8.34; P &lt; .001), especially cerebrovascular events (aOR, 22.00; 95% CI, 15.25-31.72; P &lt; .001) and thromboembolism (aOR, 17.34; 95% CI, 11.55-26.03; P &lt; .001). Racial disparities explained a median (IQR) 28.9% (21.2%-33.1%) of the increased risk in deliveries to people with SCD and between 40% and 50% of the increased risk for acute kidney failure (excess risk [ER], 56.9%; 95% CI, 54.3%-59.3%), intrauterine fetal demise (ER, 47.8%; 95% CI, 46.6%-49.1%), and eclampsia (ER, 42.1%; 95% CI, 37.9%-46.1%).Conclusions and RelevanceIn this large cross-sectional study of pregnancy outcomes in people with SCD, the risk for SMM was higher compared with deliveries among people without SCD, especially for thrombotic events, organ failure, and death. Racial disparities were associated with adverse outcomes. Our findings compel scientific, clinical, and political effort to improve outcomes for pregnant people with SCD.

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Section: Discussionmentioning

confidence: 99%

“…By 2022, the American College of Obstetricians and Gynecologists recommended low-dose aspirin use in women with SCD starting at 12-weeks gestation, 20 and a clinical trial of low-dose aspirin to prevent preeclampsia in SCD is ongoing. 21 There is not yet disease-specific All adjusted odds ratios (aORs) were significant after using the Benjamini-Yekutieli correction. aORs adjusted for patient age, public insurance status, and income quartile by zip code, as well as hospital geographical region, bed size, teaching status, and ownership.…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Severe Maternal Morbidity and Mortality in Sickle Cell Disease in the National Inpatient Sample, 2012-2018

et al. 2023

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“…Moreover, women with a higher risk of developing pre-eclampsia should take low-dose aspirin during pregnancy. 28,29 The current study emphasizes the importance of addressing maternal risk factors, such as hypertension and diabetes mellitus, in managing SCA pregnancies. These factors significantly influenced birth weight in the SCA group, while diabetes mellitus was correlated with gestational age in the control group.…”

Section: Discussionmentioning

confidence: 96%

“…Moreover, women with a higher risk of developing pre-eclampsia should take low-dose aspirin during pregnancy. 28,29…”

Section: Discussionmentioning

confidence: 99%

Sickle cell anemia in pregnant Saudi women and its impact on birth weight and gestational maturity

Eltyeb,

Ibrahim Mokhasha,

Ali Al-Makramani

et al. 2023

Journal of the Chinese Medical Association

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Background: It is well documented that sickle cell anemia (SCA) in pregnancy increases the risk of problems that can influence the growth and maturation of the newborn. Objectives: To assess the gestational maturity and birth weight of babies born to Saudi mothers with sickle cell anemia in the Jazan region. Methods: A case-control study was conducted in three hospitals in the Jazan region. An interview with a semi-structured questionnaire was used to collect data from the participants’ women, and then the birth weight was taken. Results: Of 187 delivered women, 20.3% had SCA (13% had sickle cell disease, and the remaining had sickle cell trait). Among the 38 affected mothers, 15.7% were considered to have an additional risk (7.9% had diabetes mellitus, 5.3% had hypertension, and 2.6% were smokers). The mean birth weight was 2.95± 0.40 kilograms and 2.99± 0.55 kilograms in the case and control groups, respectively. However, the low birth weight babies constitute 31% of the delivered babies in the SCA group with a weight of 2.33± 0.16 kg and 15% of the control group with a mean weight of 2.16± 0.30 kilograms. The gestational age was 39.36± 1.02 weeks in the SCA group compared to 39.5 ±1.17 weeks in the control group. Maternal age and hypertension significantly influence the birth weight in the SCA group compared to the influence of diabetes mellitus on the birth weight in the control group. Conclusion: This study indicates that SCA in pregnant mothers influences birth weight, which is more impacted by maternal age and co-morbidities. Therefore, a multidisciplinary approach must monitor these risky pregnancies well to avoid undesirable neonatal outcomes.

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Sickle cell disease and pregnancy

Carrara,

Habibi,

Benachi

et al. 2023

La Presse Médicale

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Low-dose aspirin for preventing intrauterine growth restriction and pre-eclampsia in sickle cell pregnancy (PIPSICKLE): a randomised controlled trial (study protocol)

Cited by 8 publications

References 19 publications

Severe Maternal Morbidity and Mortality in Sickle Cell Disease in the National Inpatient Sample, 2012-2018

Severe Maternal Morbidity and Mortality in Sickle Cell Disease in the National Inpatient Sample, 2012-2018

Sickle cell anemia in pregnant Saudi women and its impact on birth weight and gestational maturity

Sickle cell disease and pregnancy

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